Mechanisms of Written Exposure Therapy in Residential SUD Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- PTSD Symptom Severity
研究概览
简要总结
The goal of this clinical trial is to learn how Written Exposure Therapy (WET), a brief treatment for PTSD, works among individuals with substance use disorders (SUD) engaged in residential SUD treatment and how biology may influence treatment. The main questions it aims to answer are:
- Does WET improve PTSD and substance use outcomes among individuals with SUD+PTSD?
- Does WET improve physiological responses and craving to trauma cues?
- Do sex hormones influence changes physiological responses and craving during treatment among women?
Participants will:
- Complete WET or a neutral writing in addition to their residential SUD treatment
- Complete two laboratory sessions before and after treatment
- Complete follow-up surveys and interviews at 1- and 3-months post-treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to understand and sign informed consent
- •ability to write in English;
- •age between 18-55 (average age of menopause in the US)
- •[women only] naturally cycling (i.e., regular cycles, not on gonadal-related hormones)
- •current diagnosis of a moderate or severe DSM-5 SUD
- •current diagnosis of DSM-5 PTSD
- •sufficient memory of the trauma to write about the event
- •at least 5 business days left in their residential treatment episode (to allow for 5 treatment sessions).
排除标准
- •presence of a psychiatric or medical condition that would interfere with participation (e.g., severe, uncontrolled psychosis)
- •prescription of a PRN benzodiazepine
- •current PTSD treatment
研究组 & 干预措施
WET
This arm will receive Written Exposure Therapy in addition to residential SUD treatment.
干预措施: Written Exposure Therapy (Behavioral)
Neutral Writing
This arm will receive five sessions of neutral writing in addition to residential SUD treatment.
干预措施: Neutral Writing (Behavioral)
结局指标
主要结局
PTSD Symptom Severity
时间窗: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure of symptoms of PTSD as defined by the DSM-5. Participants are instructed to keep in mind the identified worst event when responding to the items. Items are summed to create a total score which ranges from 0-80; a total score cut-off of 33 is recommended for identifying probable PTSD.
Days of Substance Use
时间窗: Baseline, 1- and 3-Month Post-Discharge
The Timeline Follow-Back (TLFB) method will be used to assess past 30-day substance use frequency and quantity. The TLFB will be administered by phone at 1-month and 3-month post-discharge. Days of use at Baseline will ask about the 30 days prior to entering treatment.
Heart Rate (HR)
时间窗: Baseline, Intervention Sessions, Immediately after intervention
Biopac MP150 for Windows will be used to collect electrocardiogram (ECG) data at a sampling rate of 1000 Hz. ECG is measured using three disposable Ag/AgCl electrodes and data are processed using MindWare software. HR will be derived by spectral analysis of 1-min epochs with a Hamming windowing function and log transformed. HR will be measured continuously during the trauma-cue reactivity paradigm (primary outcome), and during WET treatment sessions (secondary outcome). Average HR in beats per minute will be calculated during the trauma-cue (primary) and for each 30-minute writing session (secondary).
Skin Conductance Response (SCR)
时间窗: Baseline, Intervention Sessions, Immediately after intervention
Biopac MP150 for Windows will be used to collect electrodermal activity (EDA) data at a sampling rate of 1000 Hz. EDA is measured using two finger electrodes and data are processed using MindWare software. EDA will be measured continuously during the trauma-cue reactivity paradigm (primary outcome), and during WET treatment sessions (secondary outcome). SCR will be calculated as the maximum SC amplitude during the trauma-cue adjusted for the average SC amplitude during the final 30-seconds of the rest phase (primary outcome). SCR during each WET session (secondary outcome) will be calculated as the maximum EDA amplitude during the written exposure, adjusted for baseline amplitude.
High-Frequency Heart Rate Variability (HF-HRV)
时间窗: Baseline, Intervention Sessions, Immediately after intervention
Biopac MP150 for Windows will be used to collect electrocardiogram (ECG) data at a sampling rate of 1000 Hz. ECG is measured using three disposable Ag/AgCl electrodes and data are processed using MindWare software. HF-HRV will be derived by spectral analysis of 1-min epochs with a Hamming windowing function and log transformed. HF-HRV will be derived from ECG R-R intervals (inter-beat interval). Standard recommendations for the high frequency band settings (0.12- 0.40 Hz) will be used. HF-HRV will be measured during the trauma-cue reactivity paradigm (primary outcome), and during WET treatment sessions (secondary outcome). Average HF-HRV will be calculated during the trauma-cue (primary) and for each 30-minute writing session (secondary).
Trauma-Reactive Craving
时间窗: Baseline, Intervention Sessions, Immediately after intervention, 1- and 3-Month Post-Discharge Follow-ups
The Craving Scale is a 3-item validated measure of substance use craving. It uses a scale of 0-9 to assess: (1) the strength of craving in the past 24 hours, (2) the likelihood of use in an environment they have used in before, and (3) strength of cued craving. Craving will be assessed at all time points. Craving before and after the trauma-cue reactivity paradigm will be assessed and trauma-reactive craving will be the change in craving pre/post-trauma-cue (primary outcome). During the WET Intervention Sessions, substance use craving pre- and post- writing will be assessed and trauma-reactive craving will be calculated as post-writing craving adjusted for pre-writing craving (secondary outcome).
次要结局
- Consequences of Substance Use(Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge)
研究者
Robyn Ellis
Clinician Investigator
Mclean Hospital